DePuy ATTUNE™ Total Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive

DePuy Orthopaedics, Inc.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Attune™ total Knee System.

Pre-market Notification Details

Device IDK201347
510k NumberK201347
Device Name:DePuy ATTUNE™ Total Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Applicant DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
ContactKaren Mahoney
CorrespondentMary Wood
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodeOIY  
Subsequent Product CodeJWH
Subsequent Product CodeMBH
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-21
Decision Date2020-06-18

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.